MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX KNEE SCORPION NEEDLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-4550P
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During deployment of the knee scorpion needle a small fragment of the metal distal tip broke off the suturing device.X-ray was obtained.The md determine risk out weighed the benefits.The patient was made aware and was in agreement with the md decision.Manufacturer response for arthrex knee scorpion needle, arthrex (per site reporter).This was a loaner from arthrex.Arthrex rep [name redacted], was aware and advised to dispose of product on 10/3/24.

• Brand Name: ARTHREX KNEE SCORPION NEEDLE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 20924010
• Report Number: 20924010
• Device Sequence Number: 14713082
• Product Code: MBI
• UDI-Device Identifier: 00888867307544
• UDI-Public: (01)00888867307544(17)290331(110)15240858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024
• Report Date (Section F): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AR-4550P
• Device Catalogue Number: AR-4550P
• Device Lot Number: 15240858
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2024